Product details
WHO Product ID
WHOAPI-290
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Hepatitis B and C
Type
None
Grade
Standard
INN
Sofosbuvir
Confirmation of WHO API prequalification document (version date)
Applicant organization
Matrix Pharmacorp Private Limited
Plot No. 14, 99 and 100, IDA Pashamylaram Phase-II
Patancheru, Sangareddy District,
Telangana
502307
India
APIMF Version Number
MLL/SOF/AP/001/03, April 2022
MLL/SOF/RP/001/03, April 2022
MLL/SOF/AP/001/03, April 2022/Amend-01, December 2023
MLL/SOF/RP/001/03, April 2022/Amend-01, December 2023
MLL/SOF/AP/001/03, April 2022/Amend-02, June 2024
MLL/SOF/RP/001/03, April 2022/Amend-02, June 2024
MLL/SOF/AP/001/03, April 2022/Amend-03, September 2025
MLL/SOF/RP/001/03, April 2022/Amend-03, September 2025
MLL/SOF/RP/001/03, April 2022
MLL/SOF/AP/001/03, April 2022/Amend-01, December 2023
MLL/SOF/RP/001/03, April 2022/Amend-01, December 2023
MLL/SOF/AP/001/03, April 2022/Amend-02, June 2024
MLL/SOF/RP/001/03, April 2022/Amend-02, June 2024
MLL/SOF/AP/001/03, April 2022/Amend-03, September 2025
MLL/SOF/RP/001/03, April 2022/Amend-03, September 2025
Product Grades
API specification number
STP/FPR/SOF/008/00
Storage condition
Do not store above 30°C
Storage period (months)
60
Duration type
Retest period
Packaging
Sofosbuvir is first packed in low density white polyethylene bag (LDPE), securely folded and twist-tied with a plastic rope, which is placed in another white polyethylene bag (HMLDPE) and heat sealed, then packed in a triple aluminium bag and finally placed in a HDPE drum.
API Manufacturing Site(s)
Matrix Pharmacorp Private Limited
Unit 8, Gaitula Chodavaram, Poosapatirega Mandal, Vizianagaram
Andhra Pradesh
535 204
India